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Inspection KPI's, Who Has Examles and What is Measured?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by MIGUEL LUNA, Jan 28, 2020.

  1. MIGUEL LUNA

    MIGUEL LUNA Member

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    Hello.
    We are being tasked to come up with KPI's for the QC Inspectors and I can't seem to come with any.
    Does anyone have some examples I can check out?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can I ask why you are being asked to do this?
     
  3. RoxaneB

    RoxaneB Moderator Staff Member

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    In addition to Andy's question, the answers to your question will vary from field to field, industry to industry, and company to company.

    What do they already do to demonstrate how they add value to the finished product? What do they think they do that adds value to the finished product?
     
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  4. Golfman25

    Golfman25 Well-Known Member

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    As other have asked, what's the point? But a couple would be how many inspections per day? Or time to complete an inspection? Defects caught? Defects missed?
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    My concern with these types of measurables is that they aren't really KPIs, in my opinion, but rather control items or simply metrics that speak to their activities.

    # of inspections per day | Without knowing the product(s) in question, this could vary from day to day depending on changes to the product going down the line. Some products may require additional testing, requiring more time. so a quota of inspections to complete could be setting up a team for failure.

    Time to complete an inspection | See above. As well, if they notice a problem, the inspection time may increase if they need to verify their initial detection or communicate the defect. Time is subject to many variables and not necessarily a good measure to hold a QC to.

    Defects caught | This one is a double-edged sword. Folks will want the number to be low because hopefully there are no defects to catch. But at the same time, folks want the number to be high because the wants to ensure that defective product isn't reaching the customer. Not a fair KPI.

    Defects missed | Okay, I think we're on to something here, but still missing the potentially real KPI. How will the organization know if the defect was missed? How will the organization know if the missed defect was detectable by the QC team? Perhaps this metric would more accurate if it was something like "Defects Missed, But with Detectable and Tested QC Attributes". After all, not only must the defect be detectable by QC, but it also needs to be something they inspect to/for.

    The measures listed above are solid measures for discussing the activities and processes of the QC inspection team, but from my own experience, they fall short of being worthy of the designation KPI.
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed! Inspection in and of itself IS measurement. The implication is that the OP is "measuring the measuring" which in itself is a bizarre concept.
     
  7. hogheavenfarm

    hogheavenfarm Well-Known Member

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    I think this derives from the mindset that "every process needs a KPI". I actually do have KPI's for this, but they are really for me only, although some of the information does find its way into the Management Review in certain ways. As Roxane points out, these are really control systems for my own use rather than company goals. I do measure things like "amount of items inspected vs. total incoming items" since we utilize acceptance sampling, and I want to make sure we are not oversampling or undersampling. Amount of "defects in supplier items" is another important metric that sometimes finds its way into the MR when I point out suppliers that have chronic quality issues. This KPI tells me whether we have chosen good suppliers or not, we try to keep supplier quality issues under 1%. I also track "inspection by type" to make sure there is a broad sampling of inspection points in all the departments, so I am trying here to stop any defective material from progressing down the assembly line, no sense performing more labor and operations on bad parts. I also track "internal defects" and "rework" through this, which helps us determine if our own processes need to be looked at.
    So all in all, some KPI's in Quality inspection can be helpful, but I wouldnt track them unless I thought the information was useful to me, or the company bottom line.
     
  8. Golfman25

    Golfman25 Well-Known Member

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    Sure. I was just throwing stuff against the wall for the OP. But, many KPIs or metrics have these types of problems. If you don't know where the weaknesses are, you make bad decisions.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's because the KPIs have little/no relationship to the quality policy! People who apply KPIs without grasping 2 fundamentals of Quality Management will go around and around with this type of thing and never learn the lesson that you don't simply grab a KPI and apply it. As in other posts, Roxane's father used "O.T.I.S" as the foundational principles against which processes and process measurements were set. "On Time, In Spec". Once KPIs are aligned, this circular exercise of trying to find a suitable KPI goes away.
     
  10. MIGUEL LUNA

    MIGUEL LUNA Member

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    Everyone,, great discussion and I really appreciate all the feedback.
    I discussed this with the plant manager and we are in agreement. Thank you..
     
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